MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA 250; INTRAOCULAR LENS

Model Number	HOYA 250 (+22.50 D)
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Inflammation (1932); Visual Impairment (2138)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr report is being submitted to fda for outside us like products reporting."endophthalmitis" is indicated as a potential adverse event related to iol implantation in hoya ifu covered under the warnings section.(b)(4).Once the investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
Event or Problem Description
Implant date: (b)(6) 2021.(b)(6) 2021 problems: optic opacification signs of inflammation/infection; product remained in eye after clinical assessment on (b)(6) 2021, patient returned to the hospital for diagnosis and treatment as endophthalmitis.Patient was cured after 3 days of moxifloxacin, tobramycin and dexamethasone eye drops and bromfenac (sodium hydrate).Patient has recovered and is fine.
Event or Problem Description
Implant date: (b)(6) 2021.On (b)(6) 2021 problems: optic opacification.Signs of inflammation/infection; product remained in eye after clinical assessment.On (b)(6) 2021, patient returned to the hospital for diagnosis and treatment as endophthalmitis.Patient was cured after 3 days of moxifloxacin, tobramycin and dexamethasone eye drops and bromfenac (sodium hydrate).Patient has recovered and is fine.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside of the usa.The report includes additional information not available/included in the initial report.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for additional information.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The product has not been returned and the pois (post-operative inflammation summary) form has not been provided as of 26 may 2021.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 250).In addition, no abnormalities were found on the sterilization record for the lot.(e q684).Since there were no abnormalities in the sterilization record especially residual eo test result, biological indicator test result and endotoxin test, we find that the batch was sterilized appropriately.Research in our complaint database indicated there were not any similar complaints in the same production lot numbers and sterilization lot numbers.The exact root cause was not determined.However, we believe this event was not caused by our product quality.Risk analysis was conducted on the product line and failure code is noted below.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.

• Brand Name: HOYA 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 11922917
• Report Number: 3006723646-2021-00037
• Device Sequence Number: 19955996
• Product Code: HQL
• UDI-Device Identifier: 04547480480831
• UDI-Public: 04547480480831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: HOYA 250 (+22.50 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention